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RECRUITING Phase 2 ClinicalTrials.gov

A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07589595

Registry updated: 2026-10-08
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Description

The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

Interventions

  • Donanemab (Drug)
    Donanemab administered IV
  • Placebo (Drug)
    Placebo administered IV

Eligibility criteria

Inclusion Criteria: * Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months. * Have least 1 core clinical feature of dementia with Lewy bodies (DLB). * Have a score ≥20 on Montreal Cognitive Assessment (MoCA). * Meet plasma P-tau217 criteria. * Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology. * Have a CSF result consistent with the presence of alpha-synuclein pathology. * Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. Exclusion Criteria: * Have a disease or condition that could interfere with this study or is a current serious or unstable illness. * Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study. * Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study. * Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions. * Have previously received amyloid-targeting therapy. * Active immunization against amyloid-beta. * Have a centrally read MRI that does not meet study entry criteria. * Have contraindication to MRI or PET scans. * Have any contraindication to lumbar puncture.

Conditions

Cognitive Dysfunction Lewy Body Disease Synucleinopathies Amyloid

Locations

  • TrialSphere Corp — Chandler, Arizona, United States
  • HonorHealth Research Institute — Scottsdale, Arizona, United States
  • Profound Research LLC — Carlsbad, California, United States
  • Irvine Clinical Research — Irvine, California, United States
  • UCSD - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California, United States
  • Stanford Neuroscience Health Center — Palo Alto, California, United States
  • CenExel Rocky Mountain Clinical Research — Englewood, Colorado, United States
  • Ki Health Partners, LLc, dba New England Institute for Clinical Research — Stamford, Connecticut, United States
  • JEM Research Institute — Atlantis, Florida, United States
  • VIN - Aventura — Aventura, Florida, United States
  • Brain Matters Research — Delray Beach, Florida, United States
  • Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
  • Norman Fixel Institute for Neurological Diseases (FIND) — Gainesville, Florida, United States
  • Mayo Clinic in Florida — Jacksonville, Florida, United States
  • K2 Medical Research ORLANDO — Maitland, Florida, United States
  • BRP-Kendal Lakes — Miami, Florida, United States
  • Renstar Medical Research — Ocala, Florida, United States
  • Charter Research - Orlando — Orlando, Florida, United States
  • Axiom Brain Health LLC — Tampa, Florida, United States
  • Palm Beach Neurology — West Palm Beach, Florida, United States
  • Conquest Research — Winter Park, Florida, United States
  • Indiana University Health Neuroscience Center — Indianapolis, Indiana, United States
  • The University of Kansas - Clinical Research Center — Fairway, Kansas, United States
  • Massachusetts General Hospital - Charlestown — Charlestown, Massachusetts, United States
  • K2 Medical Research - Foxborough — Foxborough, Massachusetts, United States
  • Neurology Center of New England — Foxborough, Massachusetts, United States
  • Headlands Eastern MA LLC — Plymouth, Massachusetts, United States
  • QUEST Research Institute — Farmington Hills, Michigan, United States
  • Struthers Parkinson's Center — Golden Valley, Minnesota, United States
  • Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States
  • Citizens Memorial Hospital District — Bolivar, Missouri, United States
  • Summit Headlands — Portland, Oregon, United States
  • Oregon Health and Science University — Portland, Oregon, United States
  • Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
  • Gadolin Research — Beaumont, Texas, United States
  • Kerwin Medical Center — Dallas, Texas, United States
  • Houston Methodist Hospital — Houston, Texas, United States
  • The University of Texas Health Science Center at Houston — Houston, Texas, United States
  • Central Texas Neurology Consultants — Round Rock, Texas, United States
  • The University of Texas Health Science Center — San Antonio, Texas, United States
  • Re:Cognition Health — Fairfax, Virginia, United States
  • EvergreenHealth — Kirkland, Washington, United States
  • Memory Clinic Ochanomizu — Bunkyō City, Japan
  • Shonan Keiiku Hospital — Fujisawa, Japan
  • Hyogo Prefectural Harima-Himeji General Medical Center — Himeji, Japan
  • Inage Neurology and Memory Clinic — Inage, Japan
  • Nippon Medical School Musashi Kosugi Hospital — Kawasaki, Japan
  • St. Marianna University Hospital — Kawasaki, Japan
  • Kobe University Hospital — Kobe, Japan
  • Juntendo Tokyo Koto Geriatric Medical Center — Kōtoku, Japan
  • Katayama Medical Clinic — Kurashiki, Japan
  • Nagoya Ekisaikai Hospital — Nagoya, Japan
  • Nagoya University Hospital — Nagoya, Japan
  • National Center for Geriatrics and Gerontology — Ōbu, Japan
  • The University of Osaka Hospital — Suita, Japan
  • Tokyo Metropolitan Institute for Geriatrics and Gerontology — tabashi City, Japan
  • Tachikawa Hospital — Tachikawa, Japan
  • Memory Clinic Toride — Toride, Japan
  • Yokohama Minami Kyosai Hospital — Yokohama, Japan
  • Oita University Hospital — Yufu, Japan
  • Gangnam Severance Hospital, Yonsei University Health System — Gangnam-gu, South Korea
  • Inha University Hospital — Incheon, South Korea
  • Gachon University Gil Medical Center — Namdong-gu, South Korea
  • Hanyang University Seoul Hospital — Seoul, South Korea
  • Konkuk University Medical Center — Seoul, South Korea
  • Ewha Womans University Mokdong Hospital — Seoul, South Korea
  • Taipei Medical University Shuang Ho Hospital — New Taipei City, Taiwan
  • New Taipei Municipal TuCheng Hospital — New Taipei City, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Chang Gung Medical Foundation-Linkou Branch — Taoyuan, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record